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Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitRef 25 Tests/Kit
Identity
- Trade Name
- Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED25 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986815290 EUDAMED06974986815283 EUDAMED
- Basic UDI-DI
- B-06974986815290 EUDAMEDB-06974986815283 EUDAMED
- EMDN Code
- W0102030108 CANCER ANTIGEN 242 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974986815290 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED fa41f0ad-40c0-4f30-976d-5c762d8c55f2 61 fields · synced Oct 6, 2026
- EUDAMED f773363a-6a8f-4aef-a643-5260f089e06f 61 fields · synced May 18, 2026